Authors: Powers P, et al.
Title: Topiramate in adults with acute bipolar I mania: pooled results.
Reference: APA 2004, New Research Presentation.
Purpose: To determine the safety and efficacy of topiramate in adults with acute bipolar I mania.
Study design: Four randomized, double-blinded, placebo-controlled trials.
Follow up: A 3-week acute phase followed by an optional 9-week, double-blinded, extension phase.
Patients: 1,092 patients (437 topiramate, 227 lithium, and 428 placebo).
Treatment: Topiramate titrated to 400 mg/day versus lithium titrated to 1,500 mg/day.
Results: In each of the four separate trials, as well as in the pooled study of results from the four trials, topiramate failed to improve mania scores or secondary outcome measures (MADRS, CGI, BPRS, and GAS) compared with placebo. Lithium demonstrated antimanic efficacy in the two trials in which it was included. Adverse events included headache, paresthesia, nausea and diarrhea. A significant weight loss in patients was also observed with topiramate compared with placebo (–1.55 kg versus –0.44 kg).